Featured Articles
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Preventing Cross-Contamination – Operating Beyond cGMP
One critical outcome universally accepted by the pharmaceutical industry is that cross-contamination of drug substances and products in manufacturing lines cannot occur. However, the conditions driving modern pharmaceutical development and manufacturing have increased the risk of cross-contamination.
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Innovating During The COVID-19 Pandemic
Pharmaceutics International, Inc., (Pii) is a premier CDMO, offering unparalleled scientific insight and depth of product knowledge, while supplying high-quality dosage forms that enhance the lives of patients worldwide. Pii provides customized and flexible solutions across several dosage forms and has experience with a broad range of compounds.
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The Value Of Orphan Drug Designation
More than 90% of rare diseases still have no FDA-approved treatment, even though rare diseases affect more than 25 million Americans. Despite the opportunities in the orphan drug market, there are challenges that may act as barriers to entry.
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Client Oriented Project Management
8/5/2020
With the significant amount of outsourcing being done by the pharmaceutical industry, we believe project management has earned the right to be a critical factor in CDMO selection and deserves some exploration and understanding. Over our 26-year history and having successfully completed over 400 development projects, Pii has developed and refined project management operations to ensure outcomes are achieved and client expectations are exceeded. We have found that excellent project management has seven distinct features.
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Innovative Therapies Supporting 503B Of The Federal Food, Drug, And Cosmetic Act (FD&C Act)
11/24/2020
Innovative therapies including customized, patient-specific compounds, are transforming healthcare, and presenting new challenges for pharmaceutical development, manufacturing, and supply chain management. Our healthcare ecosystem is experiencing tectonic shifts and providing a reliable supply of safe and effective medicines for hospitals and clinics to use for their patients will require an innovative, problem-solving mindset.
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Drug Repurposing Advantages And Strategies
Identifying new therapeutic uses for old, existing, or available drugs is an effective strategy in discovering or developing drug molecules with new pharmacological and therapeutic indications.
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Oral Solutions & Suspensions: The Art Of Pharmacy
5/12/2022
Despite advantages, there are challenges associated with liquid dosage, such as stability and palatability, parameters that need to be considered in the design.
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Parenteral Drug Manufacturing — Innovation Begins With A Problem
6/11/2020
Developing manufacturing processes for complex parenteral drug formulations often presents some of the most challenging problems—and innovative solutions —pharmaceutical scientists and engineers face.
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Demystifying Highly Potent API And Cytotoxic Drug Products
The concept of development, process design, and manufacturing of drugs with a HPAPI or cytotoxic compounds should not be a mystery to drug sponsors using a CDMO. Gathering, organizing, and understanding critical risk data related to HPAPIs and cytotoxic drugs ensures appropriate controls are defined from concept to clinical batch manufacturing to commercial-scale manufacturing.
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Meet The Scientist — Dr. Peng Zhang
While pursuing a career as a medical doctor, Peng Zhang realized there were limited treatments for patients suffering from a variety of diseases. She made the decision to fill that void by focusing on discovering and developing therapeutics.